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Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum

Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch, Following an Accidental Dural Puncture During Post Partum Period

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05888324
Acronym
CHROBLOOD
Enrollment
98
Registered
2023-06-05
Start date
2023-06-06
Completion date
2025-06-10
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Patch, Post-Dural Puncture Headache

Keywords

Post Dural puncture headache, Epidural blood patch, Chronic headache, Epidural analgesia, Obstetric anaesthesia

Brief summary

The purpose of this study is to identify possible links between conditions for carrying out a blood patch (BP) to treat accidental post dural puncture acute headache (PDPH) in the early post partum period and occurrence of chronic headaches at 1 and 6 months.

Detailed description

It is established that accidental dural puncture promotes the onset of chronic headaches in 25 to 60% of cases but the risk factors for the occurrence of this event are not known. To identify those risk factors, the investigators will analyze the initial conditions of the accidental breach, the initial manifestations of the PDPH, the methods of carrying out the BP and the patient data. In this study, the investigators will evaluate (phone questionnaire and score) incidence of chronic headaches at 1 month and 6 months after the realization of a blood patch, incidence of chronic low back pain, impact on daily life, incidence of late recurrences of PDPH, incidence of early and distant complications In case of failure of effectiveness of the first blood patch, the investigators will search for associated factors: patient data, mode of delivery, initial PDPH, conditions for carrying out the BP.

Interventions

OTHERQuestionnaires

Questionnaires by phone at 1 and 6 months after inclusion

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age greater than or equal to 18 years old, * Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward, * Collection of non-opposition after oral and written information,

Exclusion criteria

* Patient under curatorship or guardianship * Not speaking/understanding French * BP performed in another indication * Benefiting from the AME (state medical aid)

Design outcomes

Primary

MeasureTime frameDescription
Description of the conditions of the accidental breachImmediately after BloodPatch procedureData collection of diagnosis of the accidental breach : * noted with the needle, * intrathecal passage, * postpartum positional headaches, * intrathecal catheter
Time to onsetImmediately after BloodPatch procedureDescription of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
PositionalImmediately after BloodPatch procedureDescription of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Neck painImmediately after BloodPatch procedureDescription of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Analog visual scale (AVS)Immediately after BloodPatch procedureDescription of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Neurosensory disordersImmediately after BloodPatch procedureDescription of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Completion time after childbirthImmediately after BloodPatch procedureDescription of the methods of carrying out the BloodPatch (BP)
Volume injectedImmediately after BloodPatch procedureDescription of the methods of carrying out the BloodPatch (BP)
Height of puncture compared to the initial breachImmediately after BloodPatch procedureDescription of the methods of carrying out the BloodPatch (BP)
ParesthesiasImmediately after BloodPatch procedureDescription of the methods of carrying out the BloodPatch (BP)
Adverse eventsImmediately after BloodPatch procedureDescription of the methods of carrying out the BloodPatch (BP)
Duration of strict decubitus in the immediate afterglowImmediately after BloodPatch procedureDescription of the methods of carrying out the BloodPatch (BP)
AgeImmediately after BloodPatch procedurePatient data collection
HeightImmediately after BloodPatch procedurePatient data collection
WeightImmediately after BloodPatch procedurePatient data collection
ParityImmediately after BloodPatch procedurePatient data collection
Mode of deliveryImmediately after BloodPatch procedurePatient data collection
History of headaches or migraines before pregnancyImmediately after BloodPatch procedurePatient data collection
Initial treatment (before 1st BP)Immediately after BloodPatch procedurePatient data collection NSAIDs and analgesics, sphenopalatine ganglion block, ACTH, caffeine, other
Imaging1 month after last BloodPatch procedurePatient data collection
Lumbar punction1 month after last BloodPatch procedurePatient data collection
Other examinations if performed1 month after last BloodPatch procedurePatient data collection
Complications during the initial postpartum stayImmediately after BloodPatch procedurePatient data collection

Secondary

MeasureTime frameDescription
Number of patients with chronic headachesMonth 1Score - phone questionnaire
Number of patients with chronic low back painMonth 1Score - phone questionnaire
Modified Headache Impact Questionnaire (HIT)Month 1Impact on daily life - Phone questionnaire - Headaches : "Yes/No" Low back pain, "never/rarely/from time to time/often/all the time"
Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)Month 1Score - phone questionnaire
Number of patients who have been rehospitalizedMonth 1Score - phone questionnaire
Number of patients consulted for headachesMonth 1Score - phone questionnaire
Number of patients who received complementary treatmentsMonth 1Score - phone questionnaire
Patient data collectionMonth 1In case of failure of efficacy of the 1st BP: patient data, mode of delivery, initial Post dural puncture acute headache (PDPH), conditions for carrying out the BP

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCatherine FISCHER, MD

Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026